Specialty pharmacy turnaround time impediments, facilitators, and good practices

BACKGROUND: Patients receiving specialty medications have conditions that are often complex, high cost, and high need. Prompt treatment initiation is essential for the appropriate management of many conditions treated by specialty products. Improving the turnaround time (TAT) of specialty pharmacy prescriptions helps ensure patients receive the medication they need in the necessary time frame to optimize health outcomes. Despite a clinical justification for improved TAT, there is a gap in the literature describing what factors impact these times. OBJECTIVE: To determine factors that may influence specialty pharmacy TATs and to identify good practices that specialty pharmacies use to improve TAT. METHODS: This qualitative study used 4 focus groups with specialty pharmacy subject matter experts. Each focus group represented different specialty pharmacy types, including health system, payer-associated, retail chain, and independent specialty pharmacies. Attitudes, beliefs, and experiences regarding specialty pharmacy TAT were captured. Open-ended questions and prompts eliciting impediments, facilitators, and good practices associated with specialty pharmacy TAT were asked of participants. Data were analyzed thematically. RESULTS: Fifteen individuals participated across 4 focus groups: payer-associated (n = 4), independent (n = 3), health system (n = 5), and retail chain (n = 3) specialty pharmacies. Average TATs varied across specialty pharmacy type and by prescription type (clean vs intervention). Several interconnected themes were identified, including barriers with health benefits formulary management, prior authorization delays, differences in requirements between managed care organizations, and miscommunication with physicians, among others. Five subthemes were identified during the discussion of factors influencing TAT, including patient characteristics, pharmacy characteristics, provider characteristics, clinical situations, and health benefit design and formulary considerations. Pharmacy workflow improvements through technology integration are thought to improve TAT. In addition, participants noted facilitators including specialization among pharmacists and technicians in certain diseases, particularly hepatitis C and cancer. Some good practices included using patient financial advocates, technology integration, and a structured patient onboarding process, which were found to minimize delays caused by prior authorization, communication, and formularies. CONCLUSIONS: A multitude of factors impacting specialty pharmacy prescription TAT were identified. Multidisciplinary coordination between pharmacies, physicians, and managed care organizations is essential to ensure patients receive medications in the necessary time frame to optimize health outcomes.

including health system, payer-associated, retail chain, and independent specialty pharmacies. Attitudes, beliefs, and experiences regarding specialty pharmacy TAT were captured. Open-ended questions and prompts eliciting impediments, facilitators, and good practices associated with specialty pharmacy TAT were asked of participants. Data were analyzed thematically.

RESULTS:
Fifteen individuals participated across 4 focus groups: payer-associated (n = 4), independent (n = 3), health system (n = 5), and retail chain (n = 3) specialty pharmacies. Average TATs varied across specialty pharmacy type and by prescription type (clean vs intervention). Several interconnected themes were identified, including barriers with health benefits formulary management, prior authorization delays, differences in requirements between managed care organizations, and miscommunication with physicians, among others. Five subthemes were identified during the discussion of factors influencing TAT, including patient characteristics, pharmacy characteristics, provider characteristics, clinical situations, and health benefit design and formulary considerations. Pharmacy workflow improvements through technology integration are thought to improve TAT. In addition, participants noted facilitators including specialization among pharmacists and technicians in certain diseases, particularly hepatitis C and cancer. Some good practices included using patient financial advocates, technology integration, and a structured patient onboarding process, which were found to minimize delays caused by prior authorization, communication, and formularies.

CONCLUSIONS:
A multitude of factors impacting specialty pharmacy prescription TAT were identified. Multidisciplinary coordination between pharmacies, physicians, and managed care organizations is essential to ensure patients receive medications in the necessary time frame to optimize health outcomes.

Plain language summary
Patients receiving specialty medications have conditions that are often complex, high cost, and high need, necessitating close management. Turnaround time (TAT) is the time frame in which a specialty pharmacy receives a new prescription and the prescription is ready for pick-up or delivery. Factors and good practices impacting TAT have not been extensively evaluated. This study provides insight into the factors (eg, patient, pharmacy, and provider characteristics; clinical situations; and health benefits) associated with TAT and good practices to improve TAT.

Implications for managed care pharmacy
This study provides insight into the factors associated with specialty pharmacy TAT and how to improve TAT. Participants widely agreed that prescription TAT was important for patient care, satisfaction, and outcomes. However, participants expressed a need for consistent measurement of specialty pharmacy TAT as pharmacies may use varied calculation methods. This speaks to a need for an industry-wide standardized method for specialty TAT to support performance comparisons, benchmarking, value-based care, and accreditation programs.
The use of specialty medicine has grown in recent decades, fueling parallel growth in the number of specialty pharmacies that serve patients who are prescribed specialty medications. 1,2 There are more than 700 pharmacies that have specialty pharmacy accreditation, including independent, retail chain, pharmacy benefit manager, and health plan specialty pharmacies. 2 Patients receiving specialty medications have conditions that are often complex, high cost, and high need, necessitating close management from care teams, including pharmacies. 3 Prompt treatment initiation is essential for the optimal management of a variety of complex conditions. Turnaround time (TAT) refers to the time between a specialty pharmacy receiving a new prescription and the prescription being ready for pick-up or scheduled for delivery. TAT captures an essential element of prompt treatment initiation, as patients cannot begin treatment until their medication is available from the pharmacy. A review of recent randomized trials demonstrated the link between rapid initiation of antiretroviral drugs (including same-day start) and improved outcomes for patients with HIV, including retention, viral suppression at 12 months, and mortality. 4 The World Health Organization guidelines recommend that "rapid antiretroviral therapy initiation should be offered to all people living with HIV following a confirmed HIV diagnosis and clinical assessment," citing high-quality evidence for adults and adolescents. 5 Additionally, early initiation of treatment in early rheumatoid arthritis with disease-modifying antirheumatic drugs is linked to higher remission rates and reduced joint damage and disability. 6 Further, recent studies have demonstrated an association between increased time to treatment initiation and worsened outcomes for many types of cancer, including an increased risk of mortality. 7,8 Given this body of evidence, minimizing TAT is critical for specialty pharmacies to reduce the overall time to treatment and improve patient outcomes.
Studies also demonstrate that specialty pharmacies can effectively reduce TAT through good practices. 9 For example, evidence suggests that prior authorization is a frequent cause for longer TAT. In 2017, an integrated specialty pharmacy model found that the early integration of pharmacists making initial efficacy recommendations and assisting with prior authorization and appeals ultimately resulted in a reduction in the time to medication approval from 67 days to 15 days (78% reduction). Furthermore, time to medication initiation for patients with hepatitis C was reduced from 82 days to 26 days (68% reduction). 10 Although this study was published at a time when hepatitis C agents were more novel, it demonstrates that there are ways to facilitate reduced time to medication initiation when barriers to medication access exist. Additional evidence comparing clinic-based and external specialty pharmacies found that clinic-based pharmacies had significantly shorter TATs than external pharmacies, in part because of their use of pharmacy liaisons to manage prior authorization and appeals. 11 Exploring the factors associated with TAT and good practices that pharmacies can use to improve TAT will fill a critical gap and provide additional justification for specialty pharmacy TAT quality measurement. There is very little information concerning the challenges that pharmacies face and factors that may improve TAT. Thus, the purpose of this study was to explore the factors associated with TAT and the good practices that pharmacies can use to improve TAT.

Methods
This qualitative study used 4 semistructured focus groups with context analysis to explore the factors associated with TAT and good practices that pharmacies can use to improve TAT. Participants were asked a defined set of structured questions, and moderators actively managed the group dynamics to ensure not only that statements were as confidential as possible but that participants adhered to the structured questions.

DISCUSSION QUESTIONS
A focus group discussion guide (Table 1) of open-ended questions was developed based on current literature and insights from key opinion leaders of the National Association of Specialty Pharmacy (NASP). Subject matter experts also reviewed the discussion guide to ensure face validity. Topics discussed included average TAT for both overall and clean prescriptions (clean prescriptions were defined as prescriptions that did not need prior authorization, financial assistance, or other interventions); perspectives of TAT; factors influencing TAT, including barriers and challenges (eg, patient, pharmacy, and provider characteristics); and good practices to minimize TAT.

PARTICIPANT ELIGIBILITY AND RECRUITMENT
We purposively sampled specialty pharmacy key informants from diverse setting types to participate in 4 focus groups. Recruitment occurred through contacts from both the NASP membership and the Pharmacy Quality Alliance (PQA) membership through electronic and phone communication. All documents were sent electronically to participants. Inclusion criteria for the focus groups included pharmacists working in the specialty pharmacy space as staffing/clinical pharmacists or in specialty pharmacy management or leadership positions. Participants were sampled for 4 focus

DATA COLLECTION
Focus group discussions were held virtually through GoToMeeting, a hosting platform, and moderated by trained researchers. The focus groups had relatively high moderator involvement, and care was taken to adhere to the structured questions as much as possible. The moderator ensured a randomized self-introduction of the participants, reviewed the informed consent document, and went over the ground rules and logistics of the focus group. The moderator would deviate from the discussion guide as necessary to clarify points, follow up on any discussion themes, track questions for completion, or probe into responses to gather pertinent information. Focus groups were recorded, and members of the research team took notes during the focus groups. Each focus group lasted approximately 60 minutes.

DATA ANALYSIS
Content analysis was used to accomplish the objectives of the study. The information captured from the focus groups was analyzed using the Dedoose qualitative research platform. 12 Data analysis occurred using a stepwise process. After each focus group, there was an immediate debriefing to review key themes and capture comments regarding the significance of the data collected. Then, the research team used an inductive thematic analysis approach to identify and code concepts and identify keywords used by respondents from the recordings. Attention was paid to recurring concepts and broad themes. Next, the research team qualified findings by focus coding to combine or eliminate categories groups that represented (1) payer-associated, (2) independent, (3) integrated delivery network (IDN), and (4) retail chain specialty pharmacy perspectives. Three to five pharmacist participants were recruited from each focus group. Payer associated was defined as specialty pharmacies associated with an insurance carrier or pharmacy benefits manager. Independent specialty pharmacies were defined as locally owned and operated within the communities they serve. IDNs were defined as specialty pharmacies associated with a health system that provides acute or chronic clinical care in the inpatient or outpatient setting. Retail chain pharmacies were defined as specialty pharmacies within major chains with pharmacies in multiple states or at least 10 community pharmacies in multiple cities. Exclusion criteria included those unable to share their experiences from the specialty pharmacy setting, because of either company policy or other conflicts of interest.

PARTICIPANT PRIVACY AND INFORMED CONSENT
All participants provided informed consent before the focus groups began. In advance of each focus group, participants were sent a logistics and ground rules document requesting that only first names be used during discussions and that they not identify their facility other than to state overarching characteristics for clarification purposes, such as specialty pharmacy type (eg, independent) or location (eg, urban or rural). Finally, it was requested that the discussions that occurred within the focus group be kept confidential and not shared elsewhere.

Question group Interview questions and prompts
Perspectives of specialty pharmacy TAT • Tell us about the steps the pharmacy takes from receiving a new prescription to having a prescription being ready for pick-up or scheduled for delivery.
• If you had to estimate, what is the average specialty TAT in your facility?
• Please tell us what barriers there may be to having a prescription ready for pick-up or scheduled for delivery?
Factors influencing specialty pharmacy TAT • What is the impact of the patient's clinical situation on TAT?
• What is the impact of insurance design or formulary management on TAT?
• What patient characteristics impact specialty pharmacy TAT, if any?
• What pharmacy characteristics impact specialty pharmacy TAT, if any?
• What provider characteristics impact specialty pharmacy TAT, if any?
• Are TATs different across various drug classes? Improvement in specialty pharmacy TAT • What facilitators would improve TAT?
• What are good practices that pharmacies may use to improve their TAT?
Final thoughts • What final thoughts about TAT that you would like to share?
• Do you have any further questions about the study that we can answer for you? TAT = turnaround time.

TABLE 1 Focus Groups: Structured Interview Questions and Discussion Prompts
Thematic analysis yielded 6 key themes: (1) prescription processing steps, (2) average TATs, (3) perceptions of TAT, (4) factors influencing TAT, (5) key barriers to TAT, and (6) key facilitators and good practices to improve TAT. Participants provided specific examples of attitudes, beliefs, and experiences regarding specialty pharmacy TAT.

THEME 1: PRESCRIPTION PROCESSING STEPS
When asked about the steps the pharmacy takes from receiving a new prescription to having a prescription ready for pick-up or scheduled for delivery, processing varied slightly across specialty pharmacy types. All 4 types noted data entry; prior authorization, when necessary; prescription filling; and a final check by the pharmacist before the prescription is ready. Other steps in the process, such as new patient pharmacy enrollment, an initial check by the pharmacist, new patient outreach, outreach to the patient about cost, and payment assistance, were mentioned by some, but not consistently across all types. IDN specialty pharmacies had the most involved process but did not indicate participation in new patient outreach. Both retail chain and independent specialty pharmacies indicated the same prescription processing steps. Table 3 provides a summary of the processing steps that were discussed across the specialty pharmacy setting types. Data are based on the 4 focus groups and depict the mentioned processing steps. There may be assumed steps that participants did not explicitly mention.

THEME 2: AVERAGE TAT
Average TATs varied across specialty pharmacy type and by prescription type (clean vs intervention). Payer-associated and IDN specialty pharmacies responded that their average TAT was approximately 2 to 3 days for a clean prescription and about 5 days if an intervention was needed. Retail chain pharmacies stated their TAT for clean prescriptions was 2 days and 5 to 6 days for prescriptions requiring intervention. Independent specialty pharmacies reported an average TAT of about 7 days overall. • Retail chain specialty pharmacy: "For a clean script it is a couple of days." • Payer-associated specialty pharmacy: "Clean prescription would be around 2 and a half days, but those that require interventions [with a] call to prescriber offices take around 5 days." • IDN specialty pharmacy: "If a prior authorization is needed, it is an issue, we do not know how long payers would take to review -could be up to 15 days." • Payer-associated specialty pharmacy: "It is hard to put a number to it because there are the clean ones and the more difficult ones." and themes found in the initial step. Combining coded concepts was done by discussion of the research team members.
To address the issue of consistency, 2 researchers coded data gathered from the focus groups for the frequency of concepts to enable description and interpretation of the data captured in the focus groups. After all transcripts were coded, intercoder reliability was assessed using the Cohen κ score. Methods and results from these qualitative focus groups were prepared in accordance with the consolidated criteria for reporting qualitative research checklist. 13

Results
Fifteen individuals participated across 4 focus groups: payerassociated (n = 4), independent (n = 3), IDN (n = 5), and retail chain (n = 3) specialty pharmacies. The sample was predominately female (67%), had more than 10 years of experience (73%), had obtained a Doctor of Pharmacy (PharmD) degree (100%), and were either directors (40%) or managers (47%) (  TABLE 2 and (5) health benefit design/formulary considerations. Three groups identified patients' age as a factor that influences TAT. Challenges in communication and receiving information promptly from older patients (aged 65+ years) have resulted in longer TATs for independent, IDN, and retail chain specialty pharmacies.

Characteristics of Focus Group Participants
• Retail chain specialty pharmacy: "Older populations communications could be more challenging." Most groups felt that provider specialties, compared with generalists, office staff, and technology, had an impact on TAT. • Independent specialty pharmacy: "Specialists get it more-some give more effort. Neurology and oncology seem to have more urgency." • Retail chain specialty pharmacy: "If the payer has an EPA [electronic prior authorization] process vs a paper form, that will influence TAT." There was variation regarding the perceived impact of clinical factors on TAT. For example, nearly half of the participants reported that oncology has a longer TAT, whereas the rest of the participants stated that it is shorter or can vary. • Retail chain specialty pharmacy: "Oncology is fast. There are not as many step edits and prior authorizations." • Independent specialty pharmacy: "Oncology tends to be the hardest, but physicians are responsive." Patient insurance and cost factors were perceived to influence TAT by most groups. • Retail chain specialty pharmacy: "Financial assistance. It is a big factor. Even to the manufacturer level-different market access teams-getting them started or free product to get them startedhow those are set up-forms with measurement necessitates standardization to improve patient outcomes. • Payer-associated specialty pharmacy: "It is about making sure the patient is getting the best outcome as possible." • Community specialty pharmacy: "TAT is a key measure for us to make sure patients are starting and staying on therapy." • Community specialty pharmacy: "TAT has a direct impact on adherence, adherence to outcomes, and I one hundred percent believe this is an important metric that needs to be looked at closely."

TABLE 3 Specialty Pharmacy Prescription Processing Steps
Other TAT barriers included formulary changes, financial assistance, and a patient new to a specialty therapy.

THEME 6: KEY FACILITATORS AND GOOD PRACTICES TO IMPROVE TAT
When asked about key facilitators, technology integration and partnerships with providers were the most cited for shorter TATs. Examples of technology integration are using an electronic prior authorization process and diagnosis codes on electronic prescriptions sent to the pharmacy. • IDN specialty pharmacy: "If provider is in network and we can pull labs quickly, it can decrease time in prior authorization." • Retail chain specialty pharmacy: "The clinical patient management system is important. The clinical system manages the specialty patient journey. The dispensing system is only for filling." Other key facilitators discussed included physician partnerships and a good working relationship with specialists. Numerous pharmacy services and practices that can improve TATs were discussed, including patient advocates to help with prior authorizations and financial assistance, pharmacy staff training, and a clinical system that manages the specialty patient's journey. • Payer-associated specialty pharmacy: "

Discussion
The findings from these focus groups provide insight into the factors associated with TAT and the good practices that pharmacies can use to improve TAT. Despite a clinical justification for improved TAT, there is a gap in the literature describing what factors impact these times.
signatures or taxes-when think about delayed scripts, funding is important." • Payer-associated specialty pharmacy: "Our current system requires more specific patient information to pull up patient insurance to verify their data. It has been troublesome working with third-party vendors to obtain the information that they need."

THEME 5: KEY BARRIERS TO TAT
Participants identified numerous barriers that increase TAT. The top 3 cited barriers were (1) patient communication, Several focus group participants identified provider issues as a barrier to TAT, including prescription habits, clinical information on prescriptions, and a need for prescription clarifications. • IDN specialty pharmacy: "We often get a script before a provider has set their mind on a regimen. Some send it [the prescription] in advance to work up and get prices for patients. We get things going in the background but are waiting to hear from the provider which regimen they want to use." technology integration, specifically for patient outreach and for the tracking and resolution of prior authorizations. The prior authorization process has been noted to be resource intensive and is a growing burden, especially for newer specialty medications. 17 However, technology integration in the prior authorization process was noted by participants to streamline prescription filling. Electronic prior authorization options are becoming widely available, and platforms exist that can integrate with electronic health records or are accessible via a portal. 17 The participants discussed varied patient outreach techniques via technology integration that assisted patient communications and resulted in faster TATs. Specialty pharmacists are a critical part of a patient's care team. Given the findings of this project, the sharing and implementation of good practices to facilitate shorter TATs will support the patient care that specialty pharmacies provide. Future works should focus on the sharing of good practices to drive improvements in TAT and, thus, improvements in patient care.

LIMITATIONS
Several limitations diminish the generalizability of the findings of this study. Although this study captured thoughts, experiences, and perceptions from various specialty pharmacy subject matter experts and is typical for focus group research, thoughts were elicited from only 15 specialty pharmacists. Therefore, the findings cannot be generalizable to all specialty pharmacies and pharmacists in the United States. In addition, all participants were volunteers from the PQA or NASP, and the extent to which their experiences and perspectives align with other specialty pharmacists who are not PQA or NASP members are unclear. Despite this, given the dearth of published literature on specialty pharmacy TAT, this study brings value by adding to the current body of knowledge on specialty TAT. Important information was gained related to the barriers and facilitators of TAT and good practices to improve TAT in specialty pharmacies. The data collected and insights gleaned from this study could inform a survey tool to capture insights in a statistically representative manner.

Conclusions
Multidisciplinary coordination among pharmacies, physicians, and managed care organizations is essential to ensure patients receive medications in the necessary time frame to optimize health outcomes. By identifying factors that may influence specialty pharmacy TAT, stakeholders, including specialty pharmacy teams, are better able to identify potential concerns early and support TAT goals.
Participants shared the perception that prescription TAT was important for patient care and for patient satisfaction. In addition, participants also shared the perception that ensuring timely access to specialty medications improves patient outcomes. However, participants expressed a need for consistent measurement of specialty pharmacy TAT. Participants addressed that using TAT as an external metric is challenging, as pharmacies may calculate it in a variety of ways, leading to the inability for clear comparisons with external entities. Despite these challenges with current TAT calculation methodologies, participants believed that the internal use of a TAT metric drives quality improvement in their specialty pharmacy. This speaks to a need for an industry-wide standardized calculation method for specialty TAT to support performance comparisons, benchmarking, value-based care, and accreditation programs. In 2021, PQA membership endorsed a standardized specialty pharmacy measure, Specialty Pharmacy Turnaround Time, which is intended for specialty pharmacy performance measurement. This standardized measure assesses the average number of days between a specialty pharmacy receiving a new prescription for a specialty medication and the prescription being ready for pickup or scheduled for delivery, and it is calculated using dispensing system, clinical, or care management system data. The denominator is the total number of new prescriptions for medications included in the specifications. The numerator is the sum of the turnaround times, in whole days, for all prescriptions included in the denominator.
Patient communication issues, prior authorization, and cost were the most referenced barriers that resulted in slower TATs. These findings are consistent with previous studies that have examined barriers that prevent or delay medication initiation. 15 For example, as oncolytic therapy is increasingly prescribed in an outpatient setting, several barriers, such as prior authorization and financial assistance, have been identified. 16 Participants relayed that communication barriers with patients or providers often result in slower TATs. When prompted for specific instances, participants stated that reaching a patient via telephone call and patients' hesitancy in giving more information than they are used to providing to a pharmacy were the major communication issues with patients. In terms of provider communication issues, participants noted that unclear prescriptions and inconsistent provider communications both contributed to slower TATs. Other barriers, such as formulary changes and the pursuit of financial assistance, also resulted in slower TATs.
Overall, it was noted that technology integration to workflow resulted in increased efficiencies and reduced TAT. Participants stated that the facilitators of TAT included